NCT02246426

Brief Summary

This study is a multi-site, prospective, parallel arm, double-blind, randomized, controlled clinical trial to assess the efficacy of an experimental software program targeting social cognitive abilities versus a computer-based software control. Both the study and the software being investigated meet the criteria of Non-Significant Risk.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

3.5 years

First QC Date

September 16, 2014

Last Update Submit

September 24, 2019

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

  • Change in Spatial Cognition (Multiple scores are aggregated to arrive at a single composite score)

    The a priori co-primary social cognitive outcome measure will be a composite score comprised of the following standardized, validated set of assessments: * Penn Emotion Recognition Test (ER40) - A test for visual emotion perception; total percent correct. * Prosody Identification (PROID) - A test for prosody identification; total percent correct. * Penn Facial Memory Test (PFMT) -Immediate recall. A test for immediate recall of faces; total percent correct. * Penn Facial Memory Test (PFMT) - Delayed recall. A test for delayed recall of faces; total percent correct. * Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) - managing emotions subscale (D); correct responses. * The Empathic Accuracy (EA) scale; average correlation.

    At 6 weeks and At 12 weeks

  • Change in Performance on the UCSD Performance-based Skills Assessment (Co-Primary Composite Measure)

    The a priori co-primary functional measure will be the functional capacity measure of The UCSD Performance-based Skills Assessment (UPSA) - total correct. Higher scores indicate better performance. We have chosen the UPSA since it is a well-validated measure frequently used in cognitive and SC training studies; In addition, it measures functional capacity, which is expected to be affected by SC change. The UPSA is designed to assess skills in five areas (Household Chores, Communication, Finance, Transportation, and Planning Recreational Activities) that reflect general abilities that are important components of independent living. Test-retest reliability ranged from .63-.80 over follow-up periods up to 36 months in patients with schizophrenia. Among patients, the UPSA performance correlated significantly with severity of negative symptoms and of cognitive impairment but not with that of positive or depressive symptoms.

    At 6 weeks and At 12 weeks

Secondary Outcomes (13)

  • Symptoms utilizing the Positive and Negative Syndrome Scale

    At 6 weeks and At 12 weeks

  • Psychosocial Functioning utilizing the Global Functioning Scale

    At 6 weeks and At 12 weeks

  • Social Functioning utilizing the Social Functioning Scale

    At 6 weeks and At 12 weeks

  • Independent Functioning utilizing the Specific Levels of Function

    At 6 weeks and At 12 weeks

  • Functional Capacity utilizing Virtual Reality Functional Capacity Assessment

    At 6 weeks and At 12 weeks

  • +8 more secondary outcomes

Study Arms (2)

Experimental Treatment

EXPERIMENTAL

Computerized plasticity-based adaptive cognitive training requiring a total maximum of 40 treatment sessions, 3-5 times weekly, 45-60 minutes per session.

Other: Computerized plasticity-based adaptive cognitive training

Active Comparator

ACTIVE COMPARATOR

Commercially available computerized training requiring a total maximum of 40 treatment sessions, 3-5 times weekly, 45-60 minutes per session.

Other: Commercially available computerized training

Interventions

Computerized plasticity-based adaptive cognitive trainingOTHER

Computerized plasticity-based adaptive cognitive training for a total maximum of 40 treatment sessions, 3-5 times weekly, 40-60 minutes per session.

Also known as: SocialVille
Experimental Treatment
Commercially available computerized trainingOTHER

Commercially available computerized training for a total maximum of 40 treatment sessions, 3-5 times weekly, 40-60 minutes per session.

Active Comparator

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must be between 18 and 65 years old, inclusive, at the time of study screening
  • Subjects must have a diagnosis of schizophrenia as defined by an interview.
  • Subjects must demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in this research study.
  • Subjects must have been clinically stable (non-acute) for 8 weeks prior to consent; in the judgment of the Site Principal Investigator.
  • Subjects must have been maintained on a stable treatment of antipsychotics and/or other concomitant psychotropic treatment for at least 6 weeks prior to consent.
  • Subjects must have learned English before the age of 12 to ensure valid neuropsychological results.
  • Subjects must have the visual, auditory, and motor capacity to use the computerized intervention in the judgment of the consenting study staff person.
  • Subjects must have no more than a moderately severe rating on hallucinations and unusual thought content.

You may not qualify if:

  • Subjects should not have had a psychiatric hospitalization in the 8 weeks prior to consent.
  • Subjects who appear to be intoxicated or under the influence of a controlled substance on any day of assessment must be rescheduled or discontinued based upon the discretion of the site staff evaluator.
  • Subjects should not have a history of mental retardation or pervasive developmental disorder; or other neurological disorder (e.g., Traumatic Brain Injury, epilepsy, Parkinson's Disease.)
  • Subjects should not have been treated within 3 years of the date of consent with a computer-based cognitive training program manufactured by Posit Science.
  • Subjects should not be participating in a concurrent clinical trial that, in the judgment of the Site Principal Investigator, could affect the outcome of this one.
  • Subjects must not show suicidal ideation or behaviors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Greater Los Angeles VA

Los Angeles, California, 90073, United States

Location

UCLA

Los Angeles, California, 90073, United States

Location

Rush University

Chicago, Illinois, 60612, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Related Publications (3)

  • Roberts MT, Lloyd J, Valimaki M, Ho GW, Freemantle M, Bekefi AZ. Video games for people with schizophrenia. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD012844. doi: 10.1002/14651858.CD012844.pub2.

    PMID: 33539561DERIVED

  • Nahum M, Lee H, Fisher M, Green MF, Hooker CI, Ventura J, Jordan JT, Rose A, Kim SJ, Haut KM, Merzenich MM, Vinogradov S. Online Social Cognition Training in Schizophrenia: A Double-Blind, Randomized, Controlled Multi-Site Clinical Trial. Schizophr Bull. 2021 Jan 23;47(1):108-117. doi: 10.1093/schbul/sbaa085.

    PMID: 32614046DERIVED

  • Rose A, Vinogradov S, Fisher M, Green MF, Ventura J, Hooker C, Merzenich M, Nahum M. Randomized controlled trial of computer-based treatment of social cognition in schizophrenia: the TRuSST trial protocol. BMC Psychiatry. 2015 Jul 3;15:142. doi: 10.1186/s12888-015-0510-1.

    PMID: 26138715DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Kyu Lee, PhD

    Posit Science Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2014

First Posted

September 22, 2014

Study Start

March 1, 2015

Primary Completion

August 30, 2018

Study Completion

August 30, 2018

Last Updated

September 26, 2019

Record last verified: 2019-09

Locations

US(4)